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临床试验/NCT03662672
NCT03662672已完成不适用

Randomized Controlled Trial of Rib Raising as Early Treatment for Post-operative Ileus

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2018年9月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
2
主要终点
Length of Stay

研究概览

简要总结

We are conducting a randomized controlled trial the use of rib raising for post-operative ileus. Rib raising is an osteopathic manipulative technique (OMT). We will recruit all patients undergoing major abdominal surgery and once they have been enrolled, we will randomize them to receive daily rib raising or a control technique where we place hands on the back but do not apply any pressure. In preliminary studies, Rib raising has been shown to reduce post-operative ileus and hospital length of stay by up to 50%.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Major abdominal surgery (laparotomy, laparoscopy excluding simple laparoscopic appendectomy or laparoscopic cholecystectomy)

排除标准

  • Open abdomen for >72 hours
  • Prior history of major post-operative complications
  • Intolerance to anesthesia
  • Co-morbidities including osteoporosis and osteopenia
  • Spine or rib fractures
  • Pregnancy
  • Prisoners
  • History of osteopathic manipulation
  • Recruitment delayed beyond 48 hours
  • Surgeon requested exclusion

结局指标

主要结局

Length of Stay

时间窗: 0-14 days

次要结局

  • Time to first bowel movement(0-14 days)
  • Time to first flatus(0-14 days)
  • Nausea/vomiting postop(0-14 days)
  • Need for nasogastric tube postop(0-14 days)
  • Time to first meal(0-14 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nina Elizabeth Glass, MD

Assistant Professor

Rutgers, The State University of New Jersey

研究点 (2)

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